Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/01/2015
Date assigned
22/01/2015
Last edited
22/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Non-alcoholic fatty liver disease (NAFLD) is a term used to describe a range of conditions caused by a build-up of fat within the liver. A normal liver should have no, or very little, fat. Simple fatty liver, which is harmless, is common in people who are overweight or obese. Over time, however, simple fatty liver can develop into non-alcoholic steatohepatitis (NASH) where the liver becomes inflamed. At this stage, people might experience a dull ache in their abdomen but it often has no symptoms. Persistent inflammation of the liver can develop into fibrosis where fibrous scar tissue develops around liver cells and blood vessels. The liver is still able to function normally at this stage. The final stages are cirrhosis and end-stage liver disease, in which the scarring is so extensive that the liver shrinks, becomes lumpy and begins not to function normally. Recent information has shown that exercise may help people with fatty liver. It may help reduce the amount of fat in the liver by increasing the ability of the body to burn fat and increasing the sensitivity of the body to food. Evidence also suggests that exercise may help to reduce active injury and inflammation in the liver. We want to show the effect of exercise on the levels of fat, injury and inflammation in the liver and the sensitivity of the body to food. Understanding the relationship between exercise and liver injury is important in gaining acceptance of exercise in the management of fatty liver and avoiding excess weight gain.

Who can participate?
Adults aged between 18-75 with a fatty liver, drink a moderate about of alcohol, does not do a lot of exercise and are at a stable weight.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) undergo 12 weeks of supervised exercise. Those in group 2 (control group) do not attend any exercise sessions. Both groups of participants go to the research facility 5 times throughout the 12 week exercise period, in which the amount of fat in the liver is measured (using a magnetic resonance scanner) and blood tests are taken to check for liver injury and inflammation.

What are the possible benefits and risks of participating?
Being more physically active may be beneficial to the level of fat, injury and inflammation in the liver and if sustained after the study, may help in preventing other complications such as heart disease and diabetes. Participants in the intervention group have supervised exercise sessions (like a personal trainer) which will teach them about their body, show them how to exercise correctly and help them become more physically fit. Participants in the control group are given the opportunity to have an individualised exercise programme. There are minimal risks to taking part in the exercise programme.

Where is the study run from?
University of Newcastle upon Tyne (UK)

When is the study starting and how long is it expected to run for?
January 2014 to November 2014

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Ms Julia Maddison

Trial website

Contact information

Type

Scientific

Primary contact

Ms Julia Maddison

ORCID ID

Contact details

University of Newcastle upon Tyne
Mitochondrial Research Group
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14948

Study information

Scientific title

The effect of exercise on liver lipid in people with fatty liver with moderate alcohol intake

Acronym

Study hypothesis

To characterise the effects of resistance exercise upon factors which influence the development and progression of fatty liver in people who regularly consume a moderate amount of alcohol.
1. The primary aim is to observe whether performing a programme of resistance exercise reduces liver fat in people diagnosed with fatty liver in the absence of any changes in alcohol consumption.
2. The secondary aims are to understand the influence of resistance exercise upon factors which influence the development and progression of fatty liver to steatohepatitis: insulin sensitivity, lipid oxidation, regional adiposity, and cytokine production. In combination, these observations will provide the first report of resistance exercise upon fatty liver with continued alcohol intake and its underlying mechanisms. These novel observations will lay the foundation for a larger study to define the effectiveness of resistance exercise as a part of the clinical care of people with fatty liver who continue to drink alcohol.

Ethics approval

Sunderland NRES committee, 06/03/2013, ref: 12/NE/0411

Study design

Non-randomised; Interventional

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Topic: Hepatology; Subtopic: Hepatology; Disease: All Hepatology

Intervention

Participants will undergo five metabolic assessment visits to the research facility, interspersed by either 12 weeks of supervised exercise therapy or continue their normal care.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Liver lipids, abdominal fat content, insulin sensitivity, lipid oxidation and inflammation.; Timepoint(s): 12 weeks

Secondary outcome measures

N/A

Overall trial start date

01/02/2014

Overall trial end date

16/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1) Fatty liver; this is the study group.
2) Moderate alcohol consumption (18-42units/ week for men; 11-28units/week for women).
3) Sedentary; we are looking at the effect of increased exercise.
4) The person's weight needs to be stable prior to entering the study as we are interested in the independent effect of exercise.
5) Aged over 18 years.
6) Understanding of English (as without this supervised gym visits will not be possible).; Target Gender: Male & Female; Upper Age Limit 75 years ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 28; UK Sample Size: 28

Participant exclusion criteria

1) In vivo ferrous material preventing MRI examination
2) Glitazones (rosiglitazone and pioglitazone) are not permitted. All other insulin sensitising medication must be stable for previous 6 months.
3) HBA1c >9.5
4) Current weight loss or change in drinking habits
5) Vitamin E (>400UI/day), PUFAs (>2g/day) and Ursodeoxycholic acid are not permitted.
6) Currently taking drugs that can induce Steatosis/steatohepatitis: corticosteroids (parenteral administration only), amiodarone (Cordarone), Tamoxifen (Nolvadex), methotrexate (Rheumatrex, Trexall).

Recruitment start date

01/03/2014

Recruitment end date

01/03/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Mitochondrial Research Group, Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Will be presented at liver conferences such as the European Association for the Study of Livers

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes